Actively Recruiting
Study on the Effect of Atorvastatin Co-administered With Omeprazole on Statin Lactone
Led by National University Hospital, Singapore · Updated on 2025-07-02
78
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 2-arm, prospective, randomized, parallel-group, open-label, longitudinal study that lasts 30 days for each study participant. This study aims to investigate the effect of co-administration of Omeprazole with Atorvastatin versus Atorvastatin monotherapy on atorvastatin lactone level. Primary endpoint: Higher statin lactone level in intervention arm after 30 days. Secondary endpoints: Higher hs-CRP in intervention arm Lipid panel Incidence of adverse drug side effects (e.g. muscle-related or elevated LFTs
CONDITIONS
Official Title
Study on the Effect of Atorvastatin Co-administered With Omeprazole on Statin Lactone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males between 21 and 75 years old or females between 50 and 75 years old
- No contraindications to the use of Atorvastatin and Omeprazole
- Ability to comply with study requirements such as taking Atorvastatin and Omeprazole once daily and returning for follow-up after 1 month
- Capable of understanding the study requirements and providing informed written consent
- Have not taken any statins or proton pump inhibitors in the past 30 days
You will not qualify if you...
- Women of child-bearing age (younger than 50 years old)
- Pregnancy, planning to conceive, or breastfeeding
- Current or recent history of liver disease, kidney problems, muscle disease, or rhabdomyolysis
- Recent history of alcohol or drug abuse
- Concurrent use of other drugs that may interact with Atorvastatin or Omeprazole, such as clopidogrel
- Acute infection or illness
- Allergy to any statins or proton pump inhibitors
- Any medical condition that might affect safety or successful completion of the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National University of Singapore (NUS) MD6 Level 8
Singapore, Singapore
Actively Recruiting
Research Team
J
Junietta Lim, Bachelor of Science (Pharmacy)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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